Innovative medication packaging system

ABSTRACT

The product is a medication packaging system, primarily designed for use in long-term care facilities, with a unique method of organizing and releasing pills that promotes correct medication administration, a natural wrist action, time savings, individual identification of medications, organization and quick release of patient medications according to time pass, and it meets requirements for compliance packaging in long-term care settings. It takes into consideration the differing needs of the pharmacy filling the prescriptions and, the caregiver administering the medications to the patient. The main design of the package consists of three parts:  
     a plastic front with bubbles to encase pills, perforations used for the release of the pills, and channels to separate and assist in the release of the pills;  
     a cardboard backing that is coated with food-grade glue; and  
     a label.  
     The system is designed with key characteristics that are common to current systems in use (such as package size and glue that can be used in existing heat seal machines) so that conversion to the new system can be easy and cost effective for the pharmacy and the end user. However, the unique features (the perforated front release system, individual pill bubbles organized in rows and separated by channels, and solid backing) set this medication packaging system apart from other systems and offer significant improvements over prior art.

BACKGROUND OF THE INVENTION

[0001] This application claims the benefit of U.S. ProvisionalApplication No. 60/440,168 filed Jan. 15, 2003.

[0002] Proper medication management is critical for patients inlong-term care settings. Medication administration is a nursing functionthat is time-consuming, complicated, physically taxing, and if doneimproperly, it can cause injury or death to the patient and it can costthe nurse, facility, and pharmacy their licenses.

[0003] Most patients in long-term care settings cannot self-administertheir own medications. They need nursing staff to keep track of orderingmedications, storing the medications, and delivering medications tothem. Pharmacies serving these patients and facilities need to usespecialized packaging systems to comply with regulations and satisfy theneeds and demands of the nursing staff.

[0004] As regulations increase and as the market for medicationmanagement in long-term care settings increases, nurses are demandingbetter tools for this vital function. According to the U.S. Census, thenumber of people over the age of 85 will double between 1990 and 2010,more than double in the following decade, and continue to rise. Duringthis same time, the number of younger people who would traditionallycare for the elderly and terminally ill is decreasing. Patients inlong-term care settings take an average of eight prescriptions (and morewith over-the-counter medications added to the mix). They may need totake several of these medications at the same time each day anddifferent medications several times a day. Nursing teams are searchingfor ways of decreasing the time it takes to administer medications aswell as methods that are less physically taxing on the staff. Thepharmacy needs to fill prescriptions for these settings in packagingthat will encourage the nursing staff/patient to select its pharmacywhile keeping packaging and labor costs at a reasonable level.

[0005] A medication packaging system used in a long-term care settingmust comply with federal guidelines for compliance packaging, it mustappeal to the pharmacist filling prescriptions, and it must appeal tothe end user (usually nursing staff). Compliance packaging helps ensurethat the right medication is given to the right patient in the rightdosage, form, and route, at the right time. It also helps ensure thatthe medication has not been tampered with and helps the caregiverdocument that the above has occurred.

[0006] Current systems being used in long-term care settings fall intofour main categories: blister cards, pillow packs, cassettes, and vials(some with minor variations that combine features from two or moresystems). There are serious disadvantages to each category, some ofwhich include the following:

[0007] Blister cards (also called bubble packs and punch cards) are themost widely used system in long-term care and are produced by manymanufacturers. A blister card is a plastic sheet molded with blisters(to hold pills) which is encased in a fold-over card cut with holes oneach side (sealed with a heat-sealing machine or glued with a special“cold seal” glue). One side accommodates the blisters while the otherside is backed with foil. The pill in the blister is released when thenurse pushes it through the foil backing. It is the easiest and mostinexpensive system for the pharmacy and it is more tamper resistant thanother systems, but most cards do not work with automated fill systemsand the nurses complain of wrist injuries from having to push the pillout (an unnatural wrist and finger action). There are an increasingnumber of compensation claims and lawsuits filed by nursing staffagainst facilities using blister cards because of this unnatural wristaction. Blister cards are usually very time-consuming for the nursessince they must release the pill from one card, document, then go to thenext card, document, and the next until they have released all of thepills a patient needs for that time pass (such as 8 am).

[0008] Pillow packs (which look like clear M&M packages with theprescription labeling printed on the clear plastic envelope) areexpensive for the pharmacy, are prone to error, can be hard on thewrists when opening, make it difficult for nurses to identify eachmedication (and check orders), and it is usually necessary to destroyall medications in the pack when one order is changed (which is costlyand time-consuming). Pillow packs are usually filled via automatedsystems.

[0009] Cassettes are reusable plastic containers that may contain one ormore pills per cavity (filled manually by the pharmacist). Some complywith regulations for compliance packaging; others do not. The cassettesare reused, so there is a high risk of cross-contamination (from otherpills that have been housed in the cavities on previous fills, but moresignificantly from the spread of illness and disease on the cassettes).They are more easily tampered with, increasing the chance of drugdiversion/theft. Some have a more nurse-friendly way of releasing thepills, but these systems break open easily and discarded lids andplastic chards can create a hazardous mess. Cassettes are difficult andvery costly for the pharmacy to use.

[0010] Vials are not considered compliance packaging and should not, andin most cases cannot, be used in long-term care settings.

SUMMARY OF THE INVENTION

[0011] A new packaging system creates a new category of compliancepackaging: A front-release time pass system.

[0012] The inventor of this new system has been part of nursing teamswho administer medications in long-term care settings, has been along-term care facility administrator, works in a long-term carepharmacy, and is married to a leading geriatric consultant pharmacist.This new system answers the main concerns of the pharmacists and thenursing staffs regarding medication packaging. It releases pills in amanner unlike any other system on the market. It was developed with theintent to create a system that would be easier to open and more gentleon the nurses' wrists while being tamper-resistant and tamper-evident.Since nurses and pharmacists need to be able to identify each pill beingadministered to the patient and allow for changes to orders withouthaving to destroy all of the patient's medications, each pill should behoused in a separate cavity or bubble. If the pills could be organizedby time pass (such as all pills the patient needed to take at 8 am onTuesday), and could be released with one action, it would save the nursea great deal of time and create a system that would help ensure thatmedications were being administered as prescribed. The packaging shouldnot be too costly for the pharmacist or the pharmacist would notpurchase the cards (the product needs to be comparable to the mostpopular system—blister cards). It would also need to be able to be usedwith the expensive medication storage carts and heat sealing machinesthat a pharmacy already owns, so that changing to the new system wouldnot be cost prohibitive due to the change needed for filling and storageequipment. It should be easy to use, requiring little training.

[0013] This new system answers all of those concerns with thefront-release rows of bubbles, i.e., the lines of perforations andchannels that allow a row of individual bubbles of pills to be releasedwith one action.

[0014] Based on the facility needs, pharmacy needs, or manufacturerpreferences, the systems can be modified while still maintaining theunique method of organizing and releasing pills. The cards can bedifferent sizes and colors. The number of rows, columns, bubbles perrow, or size of bubbles can vary. The tab at the beginning of the rowcan be created in the plastic or the cardboard: In the plastic with atab extending beyond the card, in the plastic with a tab flush with thecard and containing a notch that slightly lifts the plastic from thecardboard, or by creating a half-circle cut in the cardboard at thebeginning of each row. The label can be attached to the top of the card,on the top and back of the card, or printed on the card under thebubbles. The card can be assembled using manual systems (cold sealing,heat sealing) or automated systems. The cardboard backing could be madeof clear plastic. The card could also book around the unit, making it acontained system for patients who need to use it while traveling or forself-administration. The system could be used with a die-cut card linedwith foil. The plastic bubbles and channels could be adhered tocardboard that has been perforated. There are many possible variations;however the innovation—the perforations and channels—remain the same.The key is in the manner in which the pills are organized and releasedfrom the front of the card due to the line of perforations and channels.

[0015] The following lists the packaging components illustrated on thediagrams and explains some of the features and benefits of thesecomponents.

THE DRAWINGS

[0016] A preferred embodiment of the invention is illustrated in theaccompanying drawings in which:

[0017] EXHIBIT 1A: Completed Card, Front View, sized to fit equipmentmade for blister cards and some of the cassette systems: The clearplastic front of the card, the cardboard back, and the label; the cardis disposable after all doses have been administered, reducing the riskof cross-contamination. The cost of the card will be comparable to themost frequently used system currently available and over time, it shouldcost less, because it uses less materials.

[0018] a. Perforations. A line of perforations is cut into the clearplastic on each side of the bubbles. The perforations are spaced toallow for easy release of the row of bubbles, while maintaining theintegrity of the package before the pills need to be released. The lineof perforations allow for a natural wrist action when the nursing staffis releasing the pills (rather than the unnatural action created whenpushing each pill in the blister card through the foil backing). Thepackaging is tamper-resistant and tamper-evident, reducing the risk ofdrug diversion/theft.

[0019] b. Plastic Channels. The plastic is molded into ridges thatcreate channels. These channels have several functions. They create atunnel that directs the pills from the card into the medication cup inan easy, orderly manner (and helps keep the pills from rolling off thewrong edge of the card before rolling into the cup). The channels alsohelp to protect the perforations and bubbles from being crushed or thecard from being bent. It is recommended that the person releasing thepills put his/her index and middle fingers on the channels surroundingthe med pod they are trying to release to better stabilize the cardwhile breaking the perforations. The channels also allow for more spacefor the glue to adhere to the plastic, creating a more solid seal.

[0020] c. Med Pod for Time pass. The med pod is the strip of bubbleswithin the perforated area. When the perforations are broken, the podlifts from the card, releasing the pills. The pills remain within thechannel until the card is slightly tipped, allowing the pills to rollinto a medication cup. The med pod is discarded after the pills withinit are released. Having all of the pills for a time pass released in oneaction significantly reduces the time it takes to prepare the pills foreach patient. It also reduces the chance of errors because thepharmacist organizes the time pass row. It also reduces errors thatoccur when a nurse is interrupted in the middle of preparing for a medpass. The pill release is quick and complete.

[0021] d. Plastic Bubbles to House Pills. The plastic is molded intobubbles large enough to hold individual pills. The bubbles are organizedin rows and columns. Vertical columns contain the same pills(prescription #1, #2, #3, etc.), creating rows that contain all of thepills a patient may need at a certain time of day (such as 8 am onThursday, 8 am on Friday, 8 am on Saturday, etc.). Nurses need to beable to identify each pill and document that they have administered thepill to the patient. The individual bubbles allow the nurse to identifyeach pill. The perforated rows (the med pod) allow for quick release ofthe pills. If the doctor changes or discontinues one of the medications,it can be removed without disturbing the other pills. There will not beresidue from the discontinued medication on the other pills, so they canbe administered as packed.

[0022] e. Tabs. In this card design, the tab is created in thecardboard, so the plastic is not cut into tabs. If it is easier for themanufacturer to cut the plastic rather than the cardboard, a circulartab can be cut into the plastic at the beginning of each row to assistthe person releasing the pills to grab the plastic and break theperforations.

[0023] f. Day/Date Pass Identifiers. Many nurses like to havemedications organized by the pharmacist by time pass (such as all 8 ammedications together) and date pass (organized and labeled by day/date).The card can be imprinted with days, dates, or numbers to help nursingstaff check if the medications were administered on the right day andtime.

[0024] g. Labeling. The card can be imprinted with a place for thepatient name and prescription information. Since medication on this carddesign is organized by medication columns and day/time pass rows, thecard could identify which column is associated with which prescription.Most pharmacies will affix a label to the top and/or back of the cardwith prescription information and bar codes.

[0025] h. Cardboard Backing. The card may be colored to assist the nursein identifying the time pass (such as 8 am medication on yellow cards).The portion of the card that is the size of the plastic front is coatedwith a food-grade glue (to adhere the plastic piece to the cardboardback). The top portion of the card is mechanically or physicallylabeled.

[0026] Exhibit 1B: Completed Card, Back View, sized to fit equipmentmade for blister cards and some of the cassette systems: The card backand label.

[0027] i. Tabs. In this card design, the tab is created in thecardboard, so the plastic is not cut into tabs. If it is easier for themanufacturer to cut the plastic rather than the cardboard, a circulartab can be cut into the plastic at the beginning of each row to assistthe person releasing the pills to grab the plastic and break theperforations.

[0028] j. Label Area. It may be printed to allow for the pharmacist tohand label it or the pharmacy may adhere prescription label and bar codeinformation.

[0029] k. Cardboard Backing. The card may be colored to assist the nursein identifying the time pass.

[0030] EXHIBIT 2A and 3A: Completed Card, Small Size, Front View(different designs): The card can be configured to match the equipmentthat the facility or pharmacy is currently using. The innovativefeatures are still applied Oust the size and organization of rows andcolumns change).

[0031] l. Perforations. A line of perforations is cut into the clearplastic on each side of the bubbles. The perforations are spaced toallow for easy release of the column of bubbles, while maintaining theintegrity of the package before the pills need to be released. The lineof perforations allows for a natural wrist action when the nursing staffis releasing the pills (rather than the unnatural action created whenpushing the pill in the blister card through the foil backing). Thepackaging is tamper-resistant and tamper-evident, reducing the risk ofdrug diversion/theft.

[0032] m. Plastic Channels. The plastic is molded into ridges thatcreate channels. These channels have several functions. They create atunnel that channels the pills from the card into a medication cup in aneasy, orderly manner (and helps keep the pills from rolling off thewrong edge of the card before rolling into the cup). The channels alsohelp to protect the perforations and the bubbles from being crushed orthe card from being bent. The channels also allow for more space for theglue to adhere to the plastic, creating a more solid seal.

[0033] n. Med Pod for Time pass. The med pod is the strip of bubbleswithin the perforated area. When the perforations are broken, the podlifts from the card, releasing the pills. The pills remain within thechannel until the card is slightly tipped, allowing the pills to rollinto a medication cup. The med pod is discarded after the pills withinit are released. Having all of the pills for a time pass released in oneaction significantly reduces the time it takes to prepare the pills foreach patient. It also reduces the chance of errors because thepharmacist organizes the time pass column. It also reduces errors thatoccur when a nurse is interrupted in the middle of preparing for a medpass. The pill release is quick and complete.

[0034] o. Plastic Bubbles to House Pills. The plastic is molded intobubbles large enough to hold individual pills. The bubbles are organizedin rows and columns. Rows contain the same pills (prescription #1, #2,#3), creating columns that contain all of the pills a patient may needat a certain time of day (such as 8 am on Thursday, 8 am on Friday, 8 amon Saturday, etc.). Nurses need to be able to identify each pill anddocument that they have administered them to the patient. The individualbubbles allow the nurse to identify each pill. The perforated columnsallow for quick release of the pills. If the doctor changes ordiscontinues one of the medications, it can be removed withoutdisturbing the other pills. There will not be residue from thediscontinued medication on the other pills, so they can be administeredas packed.

[0035] p. Tabs. In EXHIBIT 2, the tab is created in the cardboard, sothe plastic is not cut into tabs. If it is easier for the manufacturerto cut the plastic rather than the cardboard, a circular tab can be cutinto the plastic at the beginning of each column (EXHIBIT 3) to assistthe person releasing the pills to grab the plastic and break theperforations.

[0036] q. Day/Date Pass Identifiers. Many nurses like to havemedications organized by the pharmacist by time pass (such as all 8 ammedications together) and date pass (organized and labeled by day/date).The card can be imprinted with days, dates, or numbers to help nursingstaff check if the medications were administered on the right day.

[0037] r. Labeling. The card can be imprinted with a place for thepatient name and prescription information. Since medications on thiscard are organized by medication rows and day/time pass columns, thecard could identify which row is associated with which prescription.Most pharmacies would affix a label to the top and/or back of the cardwith prescription information and bar codes.

[0038] s. Cardboard Backing. The card may be color coded to assist thenurse in identifying the time pass (such as 8 am medication on yellowcards). The portion of the card that is the size of the plastic front iscoated with a food-grade glue (to adhere the plastic piece to thecardboard back). The top portion of the card is labeled or used foradhesive labeling.

[0039] EXHIBIT 2B and 3B: Completed Card, Small Size, Back View, sizedto fit equipment made some of the cassette systems (different designs):The card back and label.

[0040] t. Tabs. In EXHIBIT 2, the tab is created in the cardboard, sothe plastic is not cut into tabs. If it is easier for the manufacturerto cut the plastic rather than the cardboard, a circular tab can be cutinto the plastic at the beginning of each column (EXHIBIT 3) to assistthe person releasing the pills to grab the plastic and break theperforations.

[0041] u. Label Area. It may be printed to allow for the pharmacist tohand label or the pharmacy may adhere prescription label and bar codeinformation.

[0042] v. Cardboard Backing. The card may be colored to assist the nursein identifying the time pass.

DETAILED DESCRIPTION OF THE INVENTION: HOW IT WORKS

[0043] The innovative medication packaging system works with the heatseal machines, stays secure, and releases pills as planned, saving anaverage of 72% of the time it took to prepare the medications foradministration (over the blister card and system). The number of cardsused is comparable to the blister card and cassette systems (since theprototype uses seven-day cards containing up to six medications ratherthan the blister card with a thirty-day supply of one medication).

[0044] The following details use of the packaging system for a newpatient in a long term care facility:

[0045] Step 1: The pharmacist receives a list of the current medicationsfor the patient, and organizes them according to time pass (such asfive-morning medications, three-noon medications, and four-eveningmedications).

[0046] Step 2: The pharmacist completes the computer file for thepatient, prints the labels, gathers the medications, and puts the pillsin the bubbles in the plastic piece (each medication its own column,which forms day/time pass rows).

[0047] Step 3: The plastic piece is placed in a wooden paddle, which istopped by the cardboard backing, and the unit is put into the heatsealer.

[0048] Step 4: The unit is removed from the heat sealer, removed fromthe paddle, and the label is affixed to the top of the package.

[0049] Step 5: All of the medications for the patient are packaged,double checked by the pharmacist, and placed in the patient's bin, whichis delivered to the facility.

[0050] Step 6: The nurse receives the medications for the patient,checks the medications against the medication administration record, andplaces the bin in the medication cart.

[0051] Step 7: At the time of the med pass, the nurse removes the cardfor the patient and checks it against the medication record.

[0052] Step 8: The nurse places the medication card on a level surface,along with a medication cup. She places her fingers on the channelssurrounding the med pod strip and pulls the tab, breaking theperforations until the pod is released from the package (she discardsthe med pod strip of bubbles). She tips the card slightly toward themedication cup until the pills roll through the channel area into thecup.

[0053] Step 9: The nurse hands the cup to the patient, who takes themedication.

[0054] Step 10: The nurse records the successful med pass and replacesthe card in the bin.

[0055] The key element, the perforations on the front of the card,allows the nurse to release the pills for an entire time pass in oneeasy action. This innovation allows the nurse to identify individualpills, but release them all with one action. It allows for a morenatural wrist action, reducing the chance of wrist fatigue and injury.It saves valuable time. With the pharmacy organizing the pills by timepass and the nurse checking the medications against the medicationadministration record, it also creates a safer method, with less risk ofmedication error. The construction of the card, channels, andperforations allow for these benefits while still being cost-effectiveand labor-effective for the pharmacy.

[0056] There is no medication packaging system for long-term care likethis one. It makes significant improvements over prior art and willimprove the way medications are administered in long term care settings.

[0057] While this invention has been described and illustrated hereinwith respect to preferred embodiments, it is understood that alternativeembodiments and substantial equivalents are included within the scope ofthe invention as defined by the appended claims.

I claim:
 1. A package for containing and dispensing medicines in pillform, comprising: a cardboard backing member; a plasticized coverattached to one side of said cardboard backing member, said cover havinga plurality of bubbles arranged in elongate rows therein for containingpills; and a series of perforations and elongate channels in said coverto provide for individual release of each of the pills from the bubblesin the cover.
 2. A package as set forth in claim 1, wherein saidcardboard backing member is non-perforated.
 3. A package as set forth inclaim 1, wherein the bubbles are arranged for the release of multiplepills at one time.
 4. A package as set forth in claim 1, wherein saidrow of bubbles has a tab at an end thereof to provide for easy access tothe pills.